Molecular imaging of zirconium-89-labeled atezolizumab as a tool to investigate atezolizumab biodistribution in diffuse large B-cell lymphoma
- Conditions
- diffuse large B-cell lymphomalymphoma10025320
- Registration Number
- NL-OMON48775
- Lead Sponsor
- HOVO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Inclusion criteria, • Age 18-75 (inclusive) years
• Patients with a confirmed histologic diagnosis of diffuse large B-cell
lymphoma (DLBCL-NOS)
based upon a representative histology specimen according to the WHO
classification, revision 2016
(see appendix A)
• Ann Arbor stages II-IV
• Negative pregnancy test at study entry
• Patient is willing and able use adequate contraception during and until 5
months after the last
protocol treatment.
• Written informed consent
• Patient is capable of giving a written informed consent
Diagnosis
• All histopathological diagnoses other than DLBCL-NOS according to the WHO
classification, revision 2016, including:
- High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6
translocations
- Testicular large B-cell lymphoma
- Primary mediastinal B cell lymphoma
- Transformed indolent lymphoma
- Post-transplant lymphoproliferative disorder, Organ dysfunction
• Clinical signs of severe pulmonary dysfunction
• Clinical signs of heart failure (NYHA classification II-IV)
• Symptomatic coronary artery disease or cardiac arrhythmias not well
controlled with medication.
• Myocardial infarction during the last 6 months
• Significant renal dysfunction (serum creatinine >= 150 umol/l or clearance <=
30ml/min
Creatinine clearance may be calculated by Cockcroft -Gault formula:
CrCl = (140 - age [in years]) x weight [kg] (x 0.85 for females) /
(0.815 x serum creatinine [µmol/L])
• Inadequate hematological function: hemoglobin < 5.5 mmol/L ANC <
1.0x10^9/L or platelets < 75x10^9 /L
• Spontaneous INR > 1.5, aPTT >33
• Significant hepatic dysfunction (total bilirubin >= 1.5x upper limit of normal
(ULN) or transaminases >= 2.5 x ULN), unless related to Gilberts syndrome.
• Clinical signs of severe cerebral dysfunction
• Patients with a history of uncontrolled seizures, central nervous system
disorders or psychiatric disability judged by the investigator to be clinically
significant and adversely affecting compliance to study drugs
• Major surgery within the last 4 weeks, Known or suspected infection
• Known active bacterial, viral, fungal, mycobacterial, parasitic, or other
infection or any major episode of infection requiring treatment with IV
antibiotics or hospitalization within 4 weeks before date of registration.
Suspected active or latent tuberculosis needs to be confirmed by positive
interferon gamma (IFN-γ) release assay
• Patients known to be HIV-positive
• Active chronic hepatitis B or C infection
• Administration of a live, attenuated vaccine within 4 weeks before date of
registration or anticipation that such a live attenuated vaccine will be
required during the study and for a period of 5 months after discontinuation of
atezolizumab., Auto-immune
• Any active or history of documented autoimmune disease, including but not
limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus
erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular
thrombosis associated with antiphospholipid syndrome, Wegener*s granulomatosis,
Sjögren*s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or
glomerulonephritis.
The following exceptions are allowed: Patients with autoimmune-related
hypothyroidism or type 1 diabetes mellitus who are on stable treatment.
• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g.,
bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or
evidence of active pneumonitis per chest CT scan at screening.
• Patients with uncontrolled asthma or allergy, requiring systemic steroid
treatment
• Regular treatment with corticosteroids within the 4 weeks prior to date of
registration, unless administered for indications other than NHL at a dose
equivalent to < 30 mg/day prednisone/prednisolone., General
• Serious und
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• Description of 89Zr-atezolizumab biodistribution in DLBCL by measuring<br /><br>standardized uptake value (SUV) on the 89Zr-atezolizumab-PET scans</p><br>
- Secondary Outcome Measures
Name Time Method